We offer a comprehensive Local Contact Person for Pharmacovigilance (LCPPV) service in Spain, covering various key responsibilities in the field of pharmacovigilance. Our team is responsible for tasks such as the local management of adverse events, acting as Deputy LCPPV and Local Responsible Person for Pharmacovigilance (LRPPV, LPPV), ensuring combined coverage both as principal and deputy. Additionally, we conduct rigorous monitoring of local literature (LLM/LLS) and Regulatory Intelligence websites and Agencies to ensure early detection of potential risks. We also take care of the comprehensive management of ICSR cases, from collection to follow-up, and adapt and present educational materials for additional risk minimization measures (aRMM) according to local market needs.
Furthermore, we focus on the adequacy of Risk Management Plans (RMP) and provide training to both local affiliates on their pharmacovigilance responsibilities and to external providers on these same responsibilities, ensuring solid regulatory compliance and effective drug safety management at the local level.
08028 Barcelona